The Effect of Treatment With Teriparatide and Zoledronic Acid in Patients With Osteogenesis Imperfecta

June 22, 2021 updated by: University of Aarhus

Osteogenesis imperfecta (OI) is an inherited disease of the connective tissue. Symptoms are fractures, growth retardation, blue sclera, bad teeth, impaired hearing a.o. The aim of the present study is to investigate the effect of treatment of adult OI patients with bisphosphonate (zoledronic acid), parathyroid hormone (PTH) or placebo on bone mass, fracture risk and quality of life.

The investigators will therefore conduct a double blind, placebo controlled trial, taking genotype and previous antiresorptive therapy into account.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hvidovre, Denmark, 2650
        • Department of Endocrinology
      • Odense, Denmark, 6000
        • Department of Endocrinology M
    • Aarhus C
      • Aarhus, Aarhus C, Denmark, 8000
        • Osteoporosis clinic; department of endocrinology and metabolism

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • clinical diagnosis of osteogenesis imperfecta
  • BMD<-1.0 or

Exclusion Criteria:

  • creatinine clearance <30mL/min
  • treatment with glucocorticoids > 5mg daily during the last 3 months
  • metabolic bone disease or vitamin d deficiency
  • liver or kidney disease
  • contradictions to zoledronic acid or teriparatide
  • increased baseline risk of osteosarcoma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Zolendronic acid, 3 yr + placebo teriparatide, 2 yr
yearly intravenous infusion of 5mg active zoledronic acid in 3 yr
Drug: Zoledronic acid
antiresorptive and calcium and vitamin D
Other Names:
  • Aclasta
  • zolendronate
Experimental: teriparatide 2 yr; active zol in 3rd yr
daily injection of one dose active teriparatide for two years, active zoledronic acid in year 3.
Drug: Zoledronic acid
antiresorptive and calcium and vitamin D
Other Names:
  • Aclasta
  • zolendronate
Drug: Teriparatide
anabolic and calcium and vitamin D
Other Names:
  • Forsteo
  • PTH
Placebo Comparator: No active treatment
Observation in three years, no treatment
Other: No active treatment
Calcium and vitamin D

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone Mineral Density (BMD)
Time Frame: Three years
Dual-energy X-ray absorptiometry scans are performed at the lumbar spine, hip and whole body twice yearly. The value of the lumbar BMD is the primary outcome.
Three years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fracture risk
Time Frame: Three years
Participants are asked to report fractures throughout the study. Medical examination yearly with a focus on possible new fractures. Columnar x-ray before and after the study investigate new fractures.
Three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Bente Langdahl, MD, Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

July 1, 2020

Study Completion (Actual)

June 1, 2021

Study Registration Dates

First Submitted

August 16, 2012

First Submitted That Met QC Criteria

August 30, 2012

First Posted (Estimate)

September 5, 2012

Study Record Updates

Last Update Posted (Actual)

June 25, 2021

Last Update Submitted That Met QC Criteria

June 22, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TreatOI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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